Tirellizumab+Anlotinib VS Anlotinib for MSS-type CRC

NCT06573424 | Completed DMC

• 1 other identifier: TKI+ICIs vs TKI
• Study Type: observational
• Target: 124
• Locations: 1 country
• Sites: 1

Brief Summary

To compare the efficacy and safety of tirellizumab combined with anlotinib in the treatment of mss colorectal cancer. To investigate the effective biomarker of anlotinib combined with tiralizumab

Conditions

Colon Cancer; Immunotherapy

Keywords

Immunotherapy; Multi-omics analysis; tirellizumab; anlotinib

Outcome Measures

Primary Outcomes (1)

• PFS

  Defined as the time from the beginning of treatment to the first imaging disease progression or death (whichever occurs first)

  36 months

Secondary Outcomes (2)

• OS

  36 months

• Multiomic molecular characterization of the response to combination immunotherapy

  36 months

Study Arms (2)

combination group

Patients who have been treated with anlotinib + tislelizumab

Combination Product: Tislelizumab+anlotinib

control group

Patients who have been treated with anlotinib monotherapy

Drug: anlotinib

Interventions

Tislelizumab+anlotinib COMBINATION_PRODUCT

Patients who have been treated with anlotinib + tislelizumabline

combination group

anlotinib DRUG

Patients who have been treated with anlotinib monotherapy

control group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with advanced MSS type colorectal cancer between November 2020 and May 2023

You may qualify if:

• years old
• Patients with mss colorectal cancer who have been confirmed by pathology and have relapsed or failed multiline therapy
• Patients who have been treated with anlotinib monotherapy(12 mg qd, d1-14; 21 days per cycle) or anlotinib(12 mg qd, d1-14; 21 days per cycle)+ tislelizumab(200 mg, once every 3 weeks)
• the presence of at least one measurable target lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

You may not qualify if:

• Patients with other malignant tumors
• Prior treatment with antirotinib, anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137 or anti-CTLA-4 antibodies or any other antibody or drug that specifically targets T cell co-stimulation or checkpoint pathways
• Follow-up was less than 30 days

Sponsors & Collaborators

• fan li: lead

Study Sites (1)

Daping Hospital, Third Military Medical University

Chongqing, 400042, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Tissues were obtained from patients prior to the administration of the investigational treatment and were formalin-fixed and paraffin-embedded (FFPE). The FFPE samples were subjected to WES；The other was frozen at -80℃ for the detection and analysis of TMB and tumor immune microenvironment composition

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

anlotinib

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: August 15, 2024
• First Posted: August 27, 2024
• Study Start: May 1, 2024
• Primary Completion: July 1, 2024
• Study Completion: October 31, 2024
• Last Updated: May 1, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)